Clinical Trial News

A new FDA-approved implantable spinal cord stimulator, Inceptiv™, may offer relief for chronic pain by sensing and adjusting stimulation to block pain signals before they reach the brain.

OrsoBio raises $67M to advance weight loss drugs; Vor Bio's CRISPR-edited stem cells show success in AML therapy; Boehringer Ingelheim to test eye drug for geographic atrophy; Novartis licenses capsid from Voyager for gene therapy; Vaxcyte raises $1.3B on positive pneumococcal vaccine data.

Eligibility criteria for OAG/OHT study eyes include C/D ratio ≤ 0.8, visual field mean deviation ≥ −12 dB, BCVA 20/80 or better, and specific IOP requirements. Exclusions involve prior glaucoma surgeries, ocular conditions affecting measurements, and systemic diseases. Procedures include informed consent, ophthalmic assessments, and randomization to FE/SE implants or sham. Follow-up visits assess IOP, visual acuity, and adverse events. Statistical analysis aims to confirm non-inferiority of implant effects on IOP reduction.

Advisory committee meeting on September 9, 2024, to discuss the NDA for oral sulopenem tablets, developed by Iterum Therapeutics to treat UTIs in women. The REASSURE trial demonstrated non-inferiority of sulopenem compared to Augmentin, with a similar safety profile and no new safety signals except those linked to β-lactams. The FDA accepted the resubmitted NDA with a PDUFA action date of October 25, 2024.

Subcutaneous rituximab showed similar efficacy and safety to intravenous rituximab in non-Hodgkin lymphoma, with lower costs and shorter administration times. Education and training are crucial for increasing subcutaneous rituximab use.

Donor human milk reduces NEC risk by about half in very preterm or VLBW infants, with little to no effect on late-onset invasive infection or all-cause mortality.

Alfehaid et al. analyzed colchicine-related drug-drug interactions (DDIs) in COVID-19 patients, finding no increased risk of adverse events from potential DDIs. The study highlights the need for efficient screening and testing of DDIs using big data and clinical trial repurposing, emphasizing the importance of conservative prescribing and interaction checkers in clinical practice.

AcuraStem received a $4 million grant from CIRM to advance its UNC13A program targeting ALS and FTD, using the iNeuroRx platform to develop antisense oligonucleotides that restore normal function disrupted by TDP-43 pathology.

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Robin Dobbins, an oncology research nurse at Georgia Cancer Center, manages pediatric immunotherapy trials, supporting kids with relapsed brain tumors. Despite initial reluctance, she finds fulfillment in her role, connecting with families and contributing to ALSF-funded research, aiming for a Phase 3 trial.